The EPA is trying to figure out how to deal with releases of ethylene oxide, a toxic gas used to sterilize medical equipment that has prompted protests and calls for action in states including Georgia and Illinois.
Plugging leaks from vents and storage tanks and installing air pollution controls are among the approaches the Environmental Protection Agency is suggesting to minimize releases of the gas, which it says raises risks of cancer.
The EPA Dec. 5 said it is releasing an advanced notice of proposed rulemaking (RIN: 2060-AU37) that will allow the agency to get a better handle on what technologies and work practices are in use before deciding how to revise its National Emission Standards for Hazardous Air Pollutants for the commercial sterilizer sector. The agency will ask for public comment.
“Soliciting feedback from citizens and stakeholders is an important step in the process,” Administrator Andrew Wheeler said in a Dec. 5 statement.
The EPA has been under pressure from citizen activists to revise toxic air pollution limits for the commercial sterilizer industry since it concluded in late 2016 that ethylene oxide is at least 30 times more carcinogenic than previously understood.
Since then, citizen activists in Illinois and Georgia have been successful in persuading their governments to take action against medical sterilizer plants located in suburban communities.
After legal battles and community opposition in Illinois, Sterigenics U.S. LLC announced in September it would abandon its push to reopen its plant in Willowbrook, west of Chicago. The Illinois Environmental Protection Agency shut down the facility in February.
In Georgia, the state Environmental Protection Division and Becton Dickinson & Co. signed a consent order in October, temporarily shutting down the company’s commercial sterilization facility about 35 miles east of Atlanta.
Frustration at Slow Pace
It’s been over a year since former EPA Assistant Administrator Bill Wehrum promised to reconsider the limits for commercial sterilizers, which were set in 1994 and tweaked in 2001.
The EPA’s slow pace has frustrated residents and lawmakers, prompting Reps. Brad Schneider (D-Ill.) and Jody Hice (R-Ga.) to form a congressional task force to pressure the agency.
The EPA says it needs a data-based record before it can revise limits for the gas. The agency plans to propose limits by February, according to its regulatory agenda, after receiving comments on its advanced notice. The notice itself is about two months behind what the EPA’s own timetable indicated.
The agency said it recognizes the importance of ethylene oxide in sterilizing medical equipment. According to the Food and Drug Administration, about half of all medical devices, or more than 20 billion, are sterilized using this toxic, colorless, odorless gas each year. The FDA is considering alternative chemicals to use for sterilization.
“As EPA works to evaluate options for reducing air emissions from commercial sterilizer operations, the agency is coordinating closely with FDA and other federal partners,” the agency said.
Specifically, the EPA said it will consider several emission sources such as chamber exhaust vents. It also will consider regulating small companies that emit small amounts of ethylene oxide and currently aren’t regulated.
To that end, the EPA also plans to invoke its Clean Air Act authority to ask half of the 100-plus sterilizer companies to provide data on specific facility characteristics, control devices, work practices, and costs associated with installing and operating emission reduction measures. This action would be separate from its notice where it is seeking comment on strategies to reduce ethylene oxide releases from medical sterilizers.
Because a third of the estimated 100 facilities that use ethylene oxide to sterilize medical equipment are small businesses, the EPA said it will convene a small business advisory panel to review its actions. The agency said it will seek nominations until Dec. 20 for panelists from businesses, nonprofits, and local and state governments.
Elevated Levels in U.S. Air?
The EPA is also stepping up its efforts to monitor ethylene oxide levels near medical sterilizer companies in Lakewood, Colo., Grand Rapids, Mich., and Willowbrook as part of its follow-up to the most recent National Air Toxics Assessment from August 2018.
To date, the EPA says it found elevated levels of ethylene oxide at monitoring sites downwind of these sources. It also found lower, yet measurable, levels of the chemical at locations upwind, where facility emissions wouldn’t be expected to reach air quality monitors.
In light of this information, the EPA said it is beginning to examine whether ethylene oxide is present more broadly in the air in the U.S., and if so, at what levels.
“We believe that there is no immediate, short-term risk from the levels of ethylene oxide found in these limited air monitoring data. There is a need to better understand low levels of ethylene oxide over a longer-term period,” the agency said in November.
The agency isn’t just relying on monitors placed near the sterilizers. It said it will now monitor ethylene oxide, along with others routinely monitored at all 34 sites as part of its National Air Toxics Trends Station network.
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